Category Archives: Policy and Guidelines

Demystifying Health Information: The Drug Facts Box

By Marietta Cerami The dissemination of health information has become too complex.  The amount of content available to sift through can be overwhelming; not to mention downright frustrating if it’s not relevant to what the consumer is looking for. According … Continue reading

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Findings from Questions on FDA Guidance Regarding Responding to Unsolicited Off-Label Requests (Part II)

By Zoe Dunn As a follow up to the questions I submitted to FDA regarding the recent Guidance on providing Off-Label responses to unsolicited requests online, I had the pleasure of speaking with Jean-Ah Kang at DDMAC and getting her … Continue reading

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What We Asked the FDA

By Zoe Dunn Following the release of the draft guidance on “Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices” the response from within the industry has been less than satisfied which is not surprising.  But … Continue reading

Posted in Emerging Channels, Policy and Guidelines, Social Media Health | 2 Comments

Best Practices for Adverse Event Reporting for Sponsored and Unsponsored Web Properties

A couple weeks back, Hale Advisors hosted The Social Media Workshop Dinner, in NYC, where we gathered with some of the industry’s social media players. There were many topics discussed that night but one stood out for us that we … Continue reading

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Waiting for Godot: “How we are impacted by the lack of FDA guidelines for digital communications and why that is holding us back”

By Zoe Dunn Progress always involves risks. You can’t steal second base and keep your foot on first. – Frederick Wilcox Every Pharma client I have worked with in the last almost 20 years has said, “We are a very … Continue reading

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